title: A phase III concurrent chemoradiotherapy trial with cisplatin and paclitaxel or docetaxel or gemcitabine in unresectable non-small cell lung cancer: KASLC 0401.
abstract: OBJECTIVE
  Concurrent chemoradiotherapy (CCRT) is recommended for the management of patients with unresectable non-small cell lung cancer (NSCLC). This prospective study aimed to compare the efficacy of concurrently delivered cisplatin doublets with paclitaxel, or docetaxel, or gemcitabine.
  
  
  METHODS
  The main eligibility criteria consisted of previously untreated stage IIIB NSCLC. The subjects were randomized into three arms: paclitaxel 45 mg/m(2)/week (TP), docetaxel 20 mg/m(2)/week (DP), and gemcitabine 350 mg/m(2)/week (GP) in addition to cisplatin 20 mg/m(2)/week. Three-dimensional conformal radiotherapy was given once daily, weekly 5 fractions and the total prescription dose was 60-66 Gy. The primary endpoint was response rate, and the secondary endpoints were survival and toxicity.
  
  
  RESULTS
  A total of 101 patients were recruited into this trial of whom 93 (TP: 33, DP: 29, GP: 31) patients were treated with CCRT from March 2005 to July 2007. Similar response rates were observed across arms: TP: 63.6 %, DP: 72.4 %, GP: 61.3 % (p = 0.679). There was no statistically significant difference of median survival (TP: 27.3, DP: 27.6, GP: 16.5 months, p = 0.771). In subgroup analysis, a survival benefit of consolidation chemotherapy was not seen, but leucopenia (63.2 %) and neutropenia (68.4 %) more than grade 3 were significantly high in DP arm. The grade ≥3 radiation esophagitis was more frequent in the GP arm (22.6 %, p = 0.163).
  
  
  CONCLUSIONS
  Among the three arms, no statistically significant difference in response rate, survival, and toxicity was observed. However, clinically significant radiation toxicity was more frequent in the GP arm.
authors.affiliation: Lung and Esophageal Cancer Clinic, Chonnam National University Hwasun Hospital, 322 Seoyang-ro, Hwasun-eup, Jeonnam, 519-809, Republic of Korea.
authors.forename: In-Jae
authors.initials: IJ
authors.lastname: Oh
authors.forename: Kyu-Sik
authors.initials: KS
authors.lastname: Kim
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Kim
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Ban
authors.forename: Yong-Soo
authors.initials: YS
authors.lastname: Kwon
authors.forename: Yu-Il
authors.initials: YI
authors.lastname: Kim
authors.forename: Sung-Chul
authors.initials: SC
authors.lastname: Lim
authors.forename: Woong-Ki
authors.initials: WK
authors.lastname: Chung
authors.forename: Taek-Keun
authors.initials: TK
authors.lastname: Nam
authors.forename: Joo-Young
authors.initials: JY
authors.lastname: Song
authors.forename: Mee-Sun
authors.initials: MS
authors.lastname: Yoon
authors.forename: Sung-Ja
authors.initials: SJ
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D011832:Radiation Injuries / Q000453:epidemiology; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine